BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 600956 · Received April 29, 2005

    Report

    Report Number
    81440-2005-00015
    Event Type
    Death
    Date Received
    April 29, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 29, 2005
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT ONE OF HIS PATIENTS WAS TAKEN BACK TO THE OPERATING ROOM FOR BLEEDING. TAH-T WAS IN USE. SUBSEQUENTLY, THE PATIENT WAS DOING WELL IN THE STEP-DOWN UNIT BUT EXPIRED A FEW DAYS LATER DUE TO A BRAIN ANEURISM APPARENTLY UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART CIRCULATORY ASSIST DEVICE DSQ SYNCARDIA SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death